The Recall Desk

FDA (Devices) recall action 80697

Ortho-Clinical Diagnostics recalled 2 products on 2018-09-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-09-19
Critical
0
Units
548,301

Why these products were recalled

The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the current triglyceride interference claim states interference should not occur below 800mg/dL of triglyceride.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Devices)··2018-09-19

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Cl- Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides in serum samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2018-09-19

    Ortho-Clinical VITROS Chloride Slides Recalled for Interference Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they do not meet maximum allowable interference claims for triglycerides.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry System
    Category
    Distribution
    0 states